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510(k) K153693

Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators by Immunalysis Corporation — Product Code LAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 2016
Date Received
December 23, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gas Chromatography, Methamphetamine
Device Class
Class II
Regulation Number
862.3610
Review Panel
TX
Submission Type

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